A biosimilar is a biologic drug that is highly similar, but not identical, to an already approved biologic drug, i.e. the reference...

The Congressional Budget Office (CBO) has just released a report that seems to cast shade on recent legislative proposals that aim to...

Being a celebrity has its challenges. Adding a new one to the list, the U.S. Food and Drug Administration (FDA) has recently issued an...

This month, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., the Federal Circuit added to the ongoing patent-family drama...

mRNA-Based Vaccine and Other Therapeutics mRNA-based vaccines have become one of the most discussed technologies both inside and outside...

The district court in Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc., Civil Action No. 20-430-RGA (D. Del.) was asked...

Recent news reports have described the successful progress of at least one company, Varda Space Industries, in developing a space-based...

The FDA Citizen Petition ("CP") process is a widely used, but often seemingly fruitless tool by which interested persons and entities can...

Because judicial resources are limited, virtually all courts impose length limitations, such as word, page, or line limits, for briefing....

FDA has released an 18-page internal decision memo which for the first time lays out the agency's interpretation of how regulatory...

Admittedly, the topic of weight loss isn't the ideal “Turkey-Day” conversation starter. Nevertheless, when the discussion relates to a...

Earlier this week, in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 22-1889, 2023 U.S. App. LEXIS 29433 (Fed. Cir....